UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021581 |
|---|---|
| Receipt number | R000024882 |
| Scientific Title | A prospective study analyzing heart rate variability with combined spinal and epidural analgesia for labor analgesia |
| Date of disclosure of the study information | 2016/03/25 |
| Last modified on | 2018/12/16 20:34:29 |
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Basic information
Public title
A prospective study analyzing heart rate variability with combined spinal and epidural analgesia for labor analgesia
Acronym
Comparison of maternal heart rate variability before and after combined spinal and epidural analgesia
Scientific Title
A prospective study analyzing heart rate variability with combined spinal and epidural analgesia for labor analgesia
Scientific Title:Acronym
Comparison of maternal heart rate variability before and after combined spinal and epidural analgesia
Region
| Japan |
Condition
Condition
Pregnancy
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to compare heart rate variability before and after spinal analgesia for women undergoing labor analgesia with combined spinal and epidural analgesia and to investigate the extent to which spinal analgesia affects autonomic nervous activity balance at induction of labor analgesia.
Basic objectives2
Others
Basic objectives -Others
Changes in heart rate variability (mainly low-frequency: LF/high-frequency: HF) were compared as autonomic nervous activity balance at induction of labor analgesia.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
LF/HF rate change before and after spinal analgesia for labor.
Key secondary outcomes
Comparison of LF/HF rate change before and after spinal analgesia between cases with and without fetal heart rate deceleration at induction of labor analgesia.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Patients who requested labor analgesia with combined spinal and epidural analgesia and consented to participate in the study
Key exclusion criteria
1.If a labor analgesia with combined spinal and epidural analgesia was contraindicated because of hematologic diseases or other reasons
2.If the patient did not wish to undergo combined spinal and epidural analgesia
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | SHUNSUKE HYUGA |
Organization
Kitasato University
Division name
Anesthesiology, School of Medicine
Zip code
Address
1-15-1 Kitasato Minami-ku, Sagamihara City, Kanagawa
TEL
042-778-8606
shyuga@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | SHUNSUKE HYUGA |
Organization
Kitasato University
Division name
Anesthesiology, School of Medicine
Zip code
Address
1-15-1 Kitasato Minami-ku, Sagamihara City, Kanagawa
TEL
042-778-8606
Homepage URL
shyuga@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Kitasato University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
北里大学病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2016 | Year | 02 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1.Prospective observational study
2.March 2016 - December 2018
3.Recruitment of subjects:Pregnant women who is admitted to our hospital and meet the selection criteria.
4.We corect and analyse that HRV,age, weight, height, BMI, gestational age, Visual analog scale of pain at the time of anesthesia enforcement (VASP), VASP after anesthesia enforcement, HF, LF, cold sensation loss or decrease in the scope of the post-anesthesia, non-invasive blood pressure, oxygen saturation, heart rate, fetal heart rate and uterine contraction interval and a strength.We use HRV analysis device. HRV was analyzed at 0,5,10,15, and 30 min after injections of analgesics in the lateral position.
Management information
Registered date
| 2016 | Year | 03 | Month | 23 | Day |
Last modified on
| 2018 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024882
